Division of Hematology/Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Department of Dermatology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
J Am Acad Dermatol. 2021 Feb;84(2):354-360. doi: 10.1016/j.jaad.2020.04.057. Epub 2020 Apr 19.
Over the last 5 years, there has been a rapid growth in the number of clinical trials used to support a US Food and Drug Administration (FDA) approval for systemic therapies with labeled indications for plaque psoriasis.
We aim to evaluate the fragility of clinical trial data used to support FDA approval of therapies for psoriasis.
We reviewed the primary endpoints of the pivotal trials of all systemic medications with a labeled indication for plaque psoriasis available from Drugs@FDA.
Sixty-nine clinical trial primary endpoints met inclusion criteria and were assessed for robustness, yielding a median fragility index of 72 and a median fragility quotient of 0.19.
Efficacy and statistical analysis data for several approved medications were not available on the product label or on Drugs@FDA.
When compared with randomized controlled trials for FDA approval across various diseases, pivotal trials in psoriasis appear quite robust to changes in outcomes.
在过去的 5 年中，用于支持美国食品和药物管理局 (FDA) 批准具有斑块型银屑病适应证的系统治疗药物的临床试验数量迅速增加。
我们旨在评估用于支持 FDA 批准银屑病治疗药物的数据的脆弱性。
我们回顾了 Drugs@FDA 中所有具有斑块型银屑病适应证的系统药物的关键试验的主要终点。
69 个临床试验主要终点符合纳入标准，并评估了其稳健性，得出的中位数脆弱性指数为 72，中位数脆弱性分数为 0.19。
几种已批准药物的疗效和统计分析数据在产品标签或 Drugs@FDA 上均不可用。
与 FDA 在各种疾病的批准的随机对照试验相比，银屑病的关键性试验对结果的变化似乎相当稳健。
